A Danish Audit of Small Bowel Obstruction

NCT ID: NCT04750811

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2026-03-01

Brief Summary

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Small bowel obstruction (SBO) is a common and potentially life-threatening acute surgical condition. A minority of patients present with a clear indication for urgent surgical intervention, either on the basis of clinical or radiological assessment (clinical signs of peritonitis/sepsis; suspicion of bowel ischaemia; closed loop obstructions; irreducible herniae etc.). However, the optimal management of the remaining patients, the majority of whom present with SBO caused by abdominal adhesions, remains a topic of international debate with practice varying in different healthcare systems.

This multicentre, prospective, observational study aims to describe the current management of patients admitted with SBO in 6 acute hospitals (Bispebjerg, Herlev, Hillerød, Hvidovre, Køge, Slagelse) on the island of Sjælland, Denmark, which accounts for a 1/3 of the total Danish population.

Detailed Description

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This is a prospective, non-interventional observational study of the management and outcomes of patients admitted with SBO in Denmark.

Relevant clinicopathological demographics will be retrieved from consenting patients' medical records. An initial analysis will be performed once these patients have reached 90 days follow-up after the start of treatment. The long-term outcomes of treatment will be assessed with further analyses at 1, 3 and 5 years follow-up.

Conditions

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Bowel Obstruction Small

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Small Bowel obstruction

Patients admitted with a diagnosis of small bowel obstruction at 1 of the 6 participating centres

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* Radiological or clinical diagnosis of mechanical SBO
* Admitted to one of the 6 participating centres

Exclusion Criteria

* SBO presenting within 30 days of a previous abdominal operation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Small Bowel Obstruction Collaborative

OTHER

Sponsor Role lead

Responsible Party

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Henry Smith

Specialist Surgical Registrar, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bispebjerg Hospital

Copenhagen, County, Denmark

Site Status

Herlev Hospital

Copenhagen, , Denmark

Site Status

Hvidovre Hospital

Copenhagen, , Denmark

Site Status

Hillerød Hospital

Hillerød, , Denmark

Site Status

Zealand University Hospital

Køge, , Denmark

Site Status

Slagelse Hospital

Slagelse, , Denmark

Site Status

Countries

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Denmark

References

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Mortensen MR, Alouda M, Bond Z, Burcharth J, Finne KF, Jensen TK, Lolle I, Malik T, Ngo-Stuyt L, Nielsen LBJ, Olausson M, Skovsen AP, Tolver MA, Smith HG. One-year outcomes following operative or non-operative management of adhesional small bowel obstruction. BJS Open. 2023 Sep 5;7(5):zrad103. doi: 10.1093/bjsopen/zrad103.

Reference Type DERIVED
PMID: 37837353 (View on PubMed)

Tolver MA, AErenlund MP, Azzam M, Bjerke T, Burcharth J, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Olausson M, Skovsen AP, Smith HG. Inter-hospital variation in management of patients with small bowel obstruction in Denmark. Dan Med J. 2023 Aug 16;70(9):A01230057.

Reference Type DERIVED
PMID: 37622641 (View on PubMed)

Olausson M, Aerenlund MP, Azzam M, Bjerke T, Burcharth JFH, Dibbern CB, Jensen TK, Jordhoj JQ, Lolle I, Ngo-Stuyt L, Nielsen EO, Nielsen LBJ, Skovsen AP, Tolver MA, Smith HG. Management and short-term outcomes of patients with small bowel obstruction in Denmark: a multicentre prospective cohort study. Eur J Trauma Emerg Surg. 2023 Apr;49(2):1121-1130. doi: 10.1007/s00068-022-02171-y. Epub 2022 Nov 10.

Reference Type DERIVED
PMID: 36357790 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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P-2021-70

Identifier Type: -

Identifier Source: org_study_id

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